Regulatory compliance

Oriola Group quality management is founded on the laws and regulatory requirements applicable in the pharmaceutical sector and on quality management standards, especially ISO 9001 and GDP. Pharmaceutical distribution and wholesale are regulated by the Good Distribution Practice (GDP) of the European Medicines Agency (EMA). In Finland, compliance with the GDP is monitored by the Finnish Medicines Agency Fimea and in Sweden by the Medical Product Agency, MPA. GDP defines the common rules of handling medicines. Where applicable, Oriola Group operations are also guided by the Good Manufacturing Practices (GMP) and other regulation concerning products that come under the regulatory control, such as food and cosmetics regulation.

International regulations have been adopted into national legislation with the help of Fimea in Finland and its Swedish counterpart MPA. Oriola Group complies with national legislation in both Finland and Sweden. The regulatory requirements are included in Oriola Group internal guidelines, and all staff dealing with pharmaceuticals receive relevant training. The compliance of Oriola Group functions is continuously monitored and developed through inspections carried out by the authorities, pharmaceutical companies and internal quality auditors. Each year, Oriola Group is audited up to 80 times a year.

The management systems support the needs and special characteristics of the various business areas.

We improve people's wellbeing by ensuring the reliable and customer-friendly delivery of pharmaceuticals and health products. Oriola provides an effective and reliable link between pharmaceutical companies and consumers.